ObeseNCT01421589
Growth Hormone Treatment on Phosphocreatine Recovery in Obesity
A study testing Growth hormone treatment in people with Obese and Growth Hormone Secretion Abnormality, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Obesity is associated with reduced growth hormone (GH) secretion. Reduced GH secretion in obesity is associated with increased cardiovascular disease risk. However, it is not yet known how reduced GH increases cardiovascular disease risk in obesity. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Obese, Growth Hormone Secretion Abnormality
- What is being tested?
- Growth hormone treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Men age 18-60 years old
- BMI ≥ 30 kg/m2
- Waist circumference ≥ 102 cm
- Peak GH value of ≤ 4.2 μg/l on standard GHRH-arginine stimulation test
Who cannot join
- Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of gastric bypass procedure.
- Subjects who have a known history of diabetes, fasting blood sugar >125 mg/dl or using any anti-diabetic drugs.
- Use of Aspirin, Clopidogrel (Plavix), Warfarin (Coumadin) or other anti-coagulants
- Subjects on testosterone, glucocorticoids, anabolic steroids, GHRH, GH or IGF-1 within 3 months of enrollment.
- Changes in lipid lowering or anti-hypertensive regimen within 3 months of screening
- History of pituitary tumor, hypopituitarism, pituitary surgery, pituitary/brain radiation or traumatic brain injury or any other condition known to affect the GH axis.
Show all 11Show fewer
- Severe chronic illness including HIV, active malignancy or history of colon cancer.
- Hemoglobin < 9.0 g/dL, SGOT > 2.5 x upper limit normal, Creatinine >1.5 mg/dL, or PSA >5 ng/ml.
- Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.
- Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient.
- Contraindications to MRI scanning.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: The Effects of Short Term Growth Hormone Treatment on Skeletal Muscle Phosphocreatine Recovery in Obesity
Obesity is associated with reduced growth hormone (GH) secretion. Reduced GH secretion in obesity is associated with increased cardiovascular disease risk. However, it is not yet known how reduced GH increases cardiovascular disease risk in obesity. The investigators hypothesize that reduced GH contributes to dysfunction of the mitochondria. Therefore, the investigators hypothesize that treatment of obese subjects with reduced GH secretion with GH will improve mitochondrial function and that this improvement in mitochondrial function will contribute, in part, to the effects of GH to improve metabolic parameters in obesity. The investigators propose to study skeletal muscle mitochondria in obese subjects with reduced GH secretion using magnetic resonance spectroscopy and muscle biopsies before and after treatment with GH.
- Conditions
- Obese, Growth Hormone Secretion Abnormality
- Being tested
- Growth hormone treatment
- Keywords
- Growth hormone, GH, Obesity, Mitochondrial function, reduced growth hormone secretion
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth hormone treatmentDrug
Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Growth Hormone | Experimental | Not described Receives: Drug: Growth hormone treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phosphocreatine Recovery
The primary objective of this study is to determine the effects of growth hormone on mitochondrial function as assessed by 31P-MRS in obese subjects with reduced GH secretion. Mitochondrial function was represented by ViPCr, a measure of phosphocreatine recovery after sub-maximal exercise. Univariate regression analyses was performed to assess the relationship between the change in skeletal muscle IGF-1 mRNA after 12 weeks treatment with rhGH to change in ViPCr.
Measured: 12-weeks
Secondary outcomes (6)
Change in Circulating IGF-1 Concentration
Change in circulating IGF-1 from Baseline to 12-weeks is reported.
Measured: Baseline and 12-weeks
Change in Skeletal Muscle IGF-1 Gene Expression
Change in skeletal muscle IGF-1 gene mRNA expression from Baseline to 12-weeks is reported.
Measured: Baseline and 12-weeks
Change in Body Composition
Change in waist circumference from Baseline to 12-weeks is reported.
Measured: Baseline and 12-weeks
Change in Inflammatory Marker
Change in high sensitivity C-reactive protein (hsCRP) from Baseline to 12-weeks is reported.
Measured: Baseline and 12-weeks
Change in Insulin Sensitivity
Change in fasting glucose from Baseline to 12-weeks is reported.
Measured: Baseline and 12-weeks
Change in Phosphocreatine Recovery
Change in phosphocreatine recovery, represented by ViPCr, from Baseline to 12-weeks is reported.
Measured: Baseline and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Hideo Makimura, Massachusetts General Hospital
- Investigators
- Hideo Makimura, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421589
- Sponsor's protocol ID
- 2011-P-000770
- Status last verified
- May 2014
- First submitted
- 19 Aug 2011
- Last updated
- 1 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Short Term Growth Hormone Treatment on Skeletal Muscle Phosphocreatine Recovery in Obesity
- ClinicalTrials.gov ID
- NCT01421589
- Acronym / sponsor ID
- 2011-P-000770
- Conditions
- Obese, Growth Hormone Secretion Abnormality
- Keywords
- Growth hormone, GH, Obesity, Mitochondrial function, reduced growth hormone secretion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Aug 2011 (estimated)
- Results
- Posted 1 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is associated with reduced growth hormone (GH) secretion. Reduced GH secretion in obesity is associated with increased cardiovascular disease risk. However, it is not yet known how reduced GH increases cardiovascular disease risk in obesity. The investigators hypothesize that reduced GH contributes to dysfunction of the mitochondria. Therefore, the investigators hypothesize that treatment of obese subjects with reduced GH secretion with GH will improve mitochondrial function and that this improvement in mitochondrial function will contribute, in part, to the effects of GH to improve metabolic parameters in obesity. The investigators propose to study skeletal muscle mitochondria in obese subjects with reduced GH secretion using magnetic resonance spectroscopy and muscle biopsies before and after treatment with GH.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Growth Hormone | Experimental | Drug: Growth hormone treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men age 18-60 years old
- BMI ≥ 30 kg/m2
- Waist circumference ≥ 102 cm
- Peak GH value of ≤ 4.2 μg/l on standard GHRH-arginine stimulation test
Key exclusion criteria (11 listed)
- Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of gastric bypass procedure.
- Subjects who have a known history of diabetes, fasting blood sugar >125 mg/dl or using any anti-diabetic drugs.
- Use of Aspirin, Clopidogrel (Plavix), Warfarin (Coumadin) or other anti-coagulants
- Subjects on testosterone, glucocorticoids, anabolic steroids, GHRH, GH or IGF-1 within 3 months of enrollment.
- Changes in lipid lowering or anti-hypertensive regimen within 3 months of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth hormone treatmentGrowth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks. | Drug | Growth Hormone |
Primary outcome
Phosphocreatine Recovery
Time frame: 12-weeks
The primary objective of this study is to determine the effects of growth hormone on mitochondrial function as assessed by 31P-MRS in obese subjects with reduced GH secretion. Mitochondrial function was represented by ViPCr, a measure of phosphocreatine recovery after sub-maximal exercise. Univariate regression analyses was performed to assess the relationship between the change in skeletal muscle IGF-1 mRNA after 12 weeks treatment with rhGH to change in ViPCr.
6 secondary outcomes
Change in Circulating IGF-1 Concentration
Time frame: Baseline and 12-weeks
Change in Skeletal Muscle IGF-1 Gene Expression
Time frame: Baseline and 12-weeks
Change in Body Composition
Time frame: Baseline and 12-weeks
Change in Inflammatory Marker
Time frame: Baseline and 12-weeks
Change in Insulin Sensitivity
Time frame: Baseline and 12-weeks
Change in Phosphocreatine Recovery
Time frame: Baseline and 12-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hideo Makimura, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth hormone treatment in people with Obese and Growth Hormone Secretion Abnormality, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phosphocreatine Recovery (time frame: 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2014.